US2023400431A1PendingUtilityA1

Diagnostics systems and methods

Assignee: HEMEX HEALTH INCPriority: Jun 25, 2019Filed: Aug 28, 2023Published: Dec 14, 2023
Est. expiryJun 25, 2039(~12.9 yrs left)· nominal 20-yr term from priority
G01N 27/44721G01N 33/68G01N 21/6428G01N 2021/6439G01N 27/44726
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Claims

Abstract

A diagnostic system that includes a cartridge and a reader is discussed herein. The cartridge can contain a patient sample, such as a blood sample. The cartridge is inserted into the reader and the patient sample is analyzed. The reader contains various analysis systems, such as an electrophoresis detection system that uses electrophoresis testing to identify and quantify various components of the blood sample. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disorder, condition, disease, or infection of the patient.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An electrophoresis detection system, comprising:
 an illumination source configured to:
 during an assay run on an electrophoresis strip, emit a first stimulus, 
 during the assay run on the electrophoresis strip, emit a second stimulus, and processing circuitry programmed to: 
 generate an instruction to cause the illumination source to emit the first stimulus and the second stimulus; 
 receive multiple optical images of the electrophoresis strip, each of the multiple images captured during the assay run, including a first image captured at a first time point during the assay run when the first stimulus is emitted and a second image captured at a second time point during the assay run when the second stimulus is emitted; 
 during the assay run, detect band detection data based on the multiple optical images of the electrophoresis strip, the band detection data having:
 a detection characteristic generated from the first image, the detection characteristic of the first image detected in response to emission of the first stimulus and including one or both of band thickness and band speed of one or both of a first band and a second band, respectively, in the first image, and 
 a detection characteristic generated from the second image, the detection characteristic of the second image detected in response to emission of the second stimulus and including one or both of band thickness and band speed of one or both of the first band and the second band, respectively, in the second image; 
 
 during the assay run, identify a component associated with the band detection data based on the detection characteristic generated from the first image and the detection characteristic generated from the second image; and 
 during the assay run, transmit an identifier of the component to an output. 
   
     
     
         2 . The electrophoresis detection system of  claim 1 , wherein the first stimulus includes a first wavelength and the second stimulus includes a second wavelength. 
     
     
         3 . The electrophoresis detection system of  claim 2 , wherein the first wavelength and the second wavelength have the same value or are within a range of values. 
     
     
         4 . The electrophoresis detection system of  claim 2 , wherein the first wavelength and the second wavelength have different values. 
     
     
         5 . The electrophoresis detection system of  claim 2 , wherein the component has a peak absorption in the UV spectrum. 
     
     
         6 . The electrophoresis detection system of  claim 2 , wherein the first wavelength is in an ultraviolet (UV) spectrum and the second wavelength is in the visible spectrum. 
     
     
         7 . The electrophoresis detection system of  claim 1 , wherein the first wavelength or the second wavelength is within a range of 375-440 nm. 
     
     
         8 . The electrophoresis detection system of  claim 1 , wherein the component is conjugated with multiple stains, a first stain of the multiple stains having a peak absorption at a first wavelength of the first stimulus or within a range that includes the first wavelength, and a second stain of the multiple stains having a peak absorption at a second wavelength of the second stimulus or within a range that includes the second wavelength. 
     
     
         9 . The electrophoresis detection system of  claim 8 , wherein the first wavelength and the second wavelength are the same. 
     
     
         10 . The electrophoresis detection system of  claim 8 , wherein the first wavelength and the second wavelength are different. 
     
     
         11 . The electrophoresis detection system of  claim 8 , wherein the component is a first component conjugated to the first stain, and the processor is further configured to:
 identify the first component based on the detection characteristic generated from the first image and the detection characteristic generated from the second image of the first band of the band detection data, and   identify the second component based on the detection characteristic generated from the first image and the detection characteristic generated from the second image of the second band of the band detection data.   
     
     
         12 . The electrophoresis detection system of  claim 8 , wherein at least one of the first stain and the second stain are fluorescent, and the detection characteristic in the first image and the detection characteristic in the second image includes one or both of:
 an emission by the first stain when excited by the first stimulus, and   an emission by the second stain when excited by the second stimulus.   
     
     
         13 . The electrophoresis detection system of  claim 1 , wherein the detection characteristic generated by the first image includes a detected emission value of the component in response to the first stimulus emitted, and the detection characteristic generated by the second image includes a detected emission value of the component in response to the second stimulus emitted. 
     
     
         14 . The electrophoresis detection system of  claim 1 , wherein one of both of the detection characteristic generated by the first image and the detection characteristic generated by the second image include one or more of location, emission intensity, absorption intensity, relative comparison of a parameter of the band in the multiple optical images, or a relative comparison of a parameter of the first band of the band detection data to the parameter of one or more other bands of the band detection data in the multiple optical images of the electrophoresis strip. 
     
     
         15 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to detect the band detection data from the first band and the second band on the electrophoresis strip in more than one of the multiple optical images, and determine a position with respect to time of each of the first band and the second band between the more than one of the multiple optical images. 
     
     
         16 . The electrophoresis detection system of  claim 15 , further comprising:
 a detection module configured to, during the assay run:
 generate a first band signal representing a combination of the detection characteristic generated by the first image and the detection characteristic generated by the second image of the first band of the band detection data, 
 generate a second band signal representing a combination of the detection characteristic generated by the first image and the detection characteristic generated by the second image of the second band of the band detection data, 
 combine the first band signal and the second band signal into a combined band detection signal, and 
   the processor is further configured to, during the assay run, identify the component associated with the band detection data based on a characteristic of the combined band detection signal.   
     
     
         17 . The electrophoresis detection system of  claim 1 , further comprising an optical detector configured to:
 during the assay run, capture the first image of the electrophoresis strip at the first time point and the second image of the electrophoresis strip at the second time point, and   generate the band detection data based on the first image and the second image.   
     
     
         18 . The electrophoresis detection system of  claim 1 , wherein the multiple optical images received by the processing circuitry includes a video of the electrophoresis strip over a time period, wherein the video is acquired during the assay run. 
     
     
         19 . The electrophoresis detection system of  claim 1 , wherein the processing circuitry is further configured to output diagnostic results based on one or more of the band detection data, the component, or the identifier. 
     
     
         20 . The electrophoresis detection system of  claim 19 , wherein one or both of the identifier and the band detection data is transmitted to a remote computing device, network, or server. 
     
     
         21 . The electrophoresis detection system of  claim 1 , wherein the component includes a type or variant of hemoglobin. 
     
     
         22 . The electrophoresis detection system of  claim 1 , wherein the component includes a protein. 
     
     
         23 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to determine a quantification parameter of the band detection data, the quantification parameter including a quantity or relative quantity of the component. 
     
     
         24 . The electrophoresis detection system of  claim 23 , wherein the quantification parameter of the band detection data further includes one or more of position or intensity of the band over time during a time period that occurs during the assay run. 
     
     
         25 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to determine a qualification parameter of the band detection data. 
     
     
         26 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to, during the assay run, continuously transmit the multiple optical images to the output. 
     
     
         27 . The electrophoresis detection system of  claim 1 , wherein:
 the detection characteristic of the first image includes a light intensity value of a first band and a light intensity value of a second band in the first image, and   the detection characteristic of the second image includes a light intensity value of the first band and a second light intensity value of the second band in the second image, and   wherein the processor is further configured to, during the assay run, detect the band detection data based on a difference or a relative change of the detection characteristic of the first image to the detection characteristic of the second image.   
     
     
         28 . The electrophoresis detection system of  claim 27 , wherein the processor is further configured to, during the assay run, detect band detection data based on the difference or the relative change of the detection characteristic increasing or decreasing during the assay run from the first image to the second image. 
     
     
         29 . The electrophoresis detection system of  claim 1 , wherein:
 the detection characteristic of the first image includes a characteristic of a first signal representing light intensity values across a band width of the first band in the first image and a characteristic of a second signal representing light intensity values across a band width of the second band in the first image, and   the detection characteristic of the second image includes a characteristic of the first signal representing light intensity values across the band width of the first band in the second image and the second signal representing light intensity values across the band width of the second band in the second image.   
     
     
         30 . The electrophoresis detection system of  claim 29 , wherein the characteristic of the first signal and the second signal in the detection characteristic in the first image and the detection characteristic in the second image, respectively, include a waveform shape of the first signal and the second signal, respectively. 
     
     
         31 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to compare the detection characteristic generated by the first image and the detection characteristic generated by the second image and, during the assay run, to identify the component based on the comparison of the detection characteristic generated by the first image and the detection characteristic of the second image. 
     
     
         32 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to determine an average of a feature of the detection characteristic of the first image and the detection characteristic of the second image and, during the assay run, to identify the component based on the average. 
     
     
         33 . The electrophoresis detection system of  claim 1 , wherein the second image includes a band of interest and the first image does not include the band of interest. 
     
     
         34 . The electrophoresis detection system of  claim 1 , wherein the processor is further configured to:
 determine an effectiveness of the assay run based on the detection characteristic of the first image and the detection characteristic of the second image, and   based on the determined effectiveness of the assay run, generate an instruction to stop, continue, or re-run the assay or to output an error message or suggested solution.

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